Evaluation should include
- pharmacy, clean room, anteroom, hood, cabinet, and personnel sanitation requirements (e.g., cleaning counting trays, countertop, and equipment; hand washing)
- personnel training in identification, handling, storage, and disposal requirements for hazardous products and waste (e.g., needles, chemotherapeutics, radiopharmaceuticals, biologics, volatile or caustic chemicals, P-list and U-list products)
- designation of personnel, access, and activities for ISO Class 5 and 7 areas
- procedures to follow for accidental exposure to hazardous substances (e.g., eyewash, chemotherapy spill kit, SDS, post exposure report)
- Environmental Protection Agency (EPA), OSHA, and National Institute for Occupational Safety and Health (NIOSH) requirements for training, handling, disposing, and transporting of hazardous waste incorporated into policy
- designated standard operating procedure (SOP) for cleaning all pharmacy areas including sterile compounding areas, carts, shelves, workstations, surfaces, floors, and walls to include materials and equipment used, frequency, responsible personnel, and training, monitoring, and documenting requirements
- review of maintenance processes for equipment (e.g., laminar flow hoods, biological safety cabinets) and supplies used to ensure safety (e.g., body showers, personal protective equipment [PPE])
- quality assurance measures performed to ensure purchase, storage, handling, and sanitation of hazardous materials meet regulatory requirements and USP guidelines.
See PTCB 2.1, 2.2, 2.11, 3.1, 3.2, 3.6, 5.2 (https://www.ptcb.org/lib24watch/files/pdf/169).
See ASHP 5.6 (https://www.ashp.org/-/media/assets/professional-development/technician-program-accreditation/docs/ashp-acpe-pharmacy-technician-accreditation-standard-2018.ashx?la=en&hash=36EAA6511105A6C6BFEA4F30E193892F19E2C385).
Process/Skill Questions:
- Why is it important for the pharmacy practice that all staff handle, store, and dispose of hazardous waste correctly?
- What is aseptic technique and its role in infection control?
- What are the differences among sanitation management, infection control, and exposure control?
- What methods are used in the pharmacy to ensure infection and exposure control? Why is each important?
- Why is it personally important for pharmacy staff to handle, store, and dispose of hazardous waste correctly?
- Why are post-exposure reporting procedures important to the pharmacy and staff?
- Where are procedures for handling and processing investigational drugs found?
- How do pharmacy organizations such as the American Society of Health-System Pharmacists (ASHP) aid pharmacies in achieving and maintaining training requirements for sanitation and exposure control?
- What are REMS, and what is their role in proper handling of pharmaceuticals?